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FDA 510(k)

ANTERIOR CAPSULECTOMY CYSTITOME

K-Number: K840659 · 1984-03-16

ApplicantSharpoint, Inc.
Decision Date1984-03-16
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ANTERIOR CAPSULECTOMY CYSTITOME is the device name listed in this FDA 510(k) record. The listed applicant is Sharpoint, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840659. The device is classified under product code HNY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTERIOR CAPSULECTOMY CYSTITOME?

ANTERIOR CAPSULECTOMY CYSTITOME is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Sharpoint, Inc.. The 510(k) number is K840659.

When did ANTERIOR CAPSULECTOMY CYSTITOME receive FDA 510(k) clearance?

ANTERIOR CAPSULECTOMY CYSTITOME received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840659.

Who is the listed applicant for ANTERIOR CAPSULECTOMY CYSTITOME?

The FDA 510(k) record lists Sharpoint, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTERIOR CAPSULECTOMY CYSTITOME?

The FDA product code for ANTERIOR CAPSULECTOMY CYSTITOME is HNY.

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Other records listing Sharpoint, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K863595COATED SUTURE NEEDLEK861947SURGICAL KNIFEK840764EAR KNIVESK840855CORNEAL SCLERAL LANCEK840660POSTERIOR CAPSULOTOMY CYSTITOMEK830522STAINLESS STEEL SUTURE 316L

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Related Devices (Code: HNY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.K880345CYSTOTOMES/KNIFESMyocure, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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